NCT02112396

Brief Summary

The present study examines the efficacy of the Community Reinforcement and Family Training (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders (AUDs) using a randomized waiting list (WL) control group. It is hypothesized that after the Intervention group has received CRAFT and prior to the WL- group having received CRAFT, treatment utilization of individuals with AUDs are substantially elevated in the Intervention group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

2.6 years

First QC Date

April 1, 2014

Last Update Submit

April 9, 2014

Conditions

Alcohol DependenceAlcohol Abuse

Keywords

CRAFTConcerned Significant OthersContingency managementReinforcementFamily Intervention

Outcome Measures

Primary Outcomes (1)

  • Treatment Utilization of relative with AUD

    Treatment utilization rates of the individual holding an AUD were assessed at 3-months follow-up

    3 months

Secondary Outcomes (1)

  • Mental well-being in participating CSO

    3 months

Other Outcomes (1)

  • Drinking behavior of relative with AUD

    3 months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Subjects receive 12 sessions of Community Reinforcement and Family Training (CRAFT) immediately after study inclusion

Behavioral: Community Reinforcement and Family Training

Waiting list group

OTHER

Waiting list group members receive the Community Reinforcement and Family Training CRAFT intervention after the first follow-up (3 months post study inclusion)

Behavioral: Community Reinforcement and Family Training

Interventions

Community Reinforcement and Family TrainingBEHAVIORAL

The Intervention is based on the CRAFT literature and includes Building and sustaining motivation of CSOs, functional analysis of problem behaviors, domestic violence precautions (if mandatory), improving communication skills of CSOs, use of negative consequences of drinking behavior, positive reinforcement of clean and sober behavior, strategies to enrich CSOs lives, and strategies for inviting the addicted individual to enter treatment.

Immediate InterventionWaiting list group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CSOs of individuals with an AUD according to the Diagnostic and Statistical Manual (DSM-IV) or the International Classification of Diseases (ICD-10)
  • At least 18 years old
  • At least 15 hours of contact per week to the addicted individual

You may not qualify if:

  • History of severe domestic violence
  • Current diagnosis of drug- or alcohol dependence of CSO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Luebeck

Lübeck, Schl.-Holstein, 23538, Germany

Location

Related Publications (1)

  • Iwen J, Bischof G, Reinhardt S, Grothues J, Hapke U, John U, Freyer-Adam J, Rumpf HJ. The impact of having a loved one with alcohol consumption-related problems on subjective health status and health-risk behaviors in a general hospital sample. Subst Use Misuse. 2010 Dec;45(14):2470-80. doi: 10.3109/10826084.2010.487233. Epub 2010 Jun 10.

    PMID: 20536354BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Hans-Juergen Rumpf, PD Dr.

    University of Luebeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Hans-Jürgen Rumpf

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 14, 2014

Study Start

August 1, 2008

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

DE(1)